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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Dec. 9, 2016

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: John Glenn, Legendary Astronaut and Later Senator, Has Died John Glenn, a famed astronaut who was the first American to orbit the Earth, died Thursday. He was 95. Glenn, who went on to a distinguished career as a U.S. Senator from Ohio, had heart valve replacement surgery in 2014, CNN reported. Ohio State...

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Breast Cancer Death Rates Vary Around the World

Posted today in Medical

FRIDAY, Dec. 9, 2016 -- Breast cancer death rates are falling in the United States and many other countries, but increasing in South Korea and some Latin American countries, researchers report. The investigators looked at data from 47 countries from 1987 to 2013. They found that breast cancer death rates declined in 39 of those nations due to advances in detection and treatment over the past few decades. The largest...

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Sleep Loss Tied to Changes in Gut Bacteria

Posted today in Medical

FRIDAY, Dec. 9, 2016 -- Getting too little sleep alters the balance of bacteria in the gut, a change that's linked to certain metabolic conditions, including obesity and type 2 diabetes, new research shows. For the study, European researchers limited the sleep of nine healthy men who were a normal weight to examine how sleep loss affects the number of types of bacteria in the gut. For two days in a row, the men...

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Zika-Linked Birth Defects Surge in Colombia: CDC

Posted today in Medical

FRIDAY, Dec. 9, 2016 -- The tragedy of hundreds of babies born with devastating birth defects linked to the Zika virus is no longer confined to Brazil, a new report confirms. Colombia is now also experiencing a surge in these cases of infant microcephaly. It's a birth defect where newborns whose mothers contracted the mosquito-borne virus in pregnancy are born with too-small skulls and underdeveloped brains. A team...

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Strength Training May Prevent Side Effect of Breast Cancer Surgery

Posted today in Medical

FRIDAY, Dec. 9, 2016 -- Strength training might benefit breast cancer survivors who've undergone surgery, researchers suggest. In a small study, weightlifting appeared to help prevent swelling in the arms and chest, a common side effect of breast cancer treatment. The study included 27 breast cancer survivors who did supervised moderate-intensity strength workouts twice a week. Each woman's regimen was matched to...

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FDA Approves Avastin (bevacizumab) Plus Chemotherapy for a Specific Type of Advanced Ovarian Cancer

Posted 4 days ago in New Drug Approvals

South San Francisco, CA -- December 6, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive...

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Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide with the FDA for the Treatment of Type 2 Diabetes

Posted 5 days ago in New Drug Applications

PLAINSBORO, N.J., Dec. 5, 2016 /PRNewswire/ -- Novo Nordisk today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for semaglutide, a glucagon-like peptide-1 (GLP-1) analog administered once-weekly, for the treatment of adults with type 2 diabetes. The company also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for...

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FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes

Posted 8 days ago in New Drug Approvals

December 2, 2016 -- The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. “Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” said Jean-Marc Guettier, M.D., C.M., director of the Division of Metabolism and End...

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Monthly News Roundup - November 2016

Posted 9 days ago in Pharma Industry News

Novo Nordisk’s Xultophy 100/3.6 FDA-Approved for Type 2 Diabetes This month the U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Xultophy 100/3.6 (insulin degludec and liraglutide), a once-daily injection of insulin degludec (Tresiba), and the glucagon-like peptide-1 (GLP-1) agonist liraglutide (Victoza), used with diet and exercise to improve blood sugar control in type 2 diabetes. Xultophy is use...

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Neurocrine Announces FDA Advisory Committee Meeting to Review Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia

Posted 11 days ago in New Drug Applications

SAN DIEGO, Nov. 29, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data included in the New Drug Application (NDA) of Ingrezza (valbenazine) for the treatment of tardive dyskinesia on February 16, 2017. The FDA has granted Priority Review status to the Ingrezza NDA with a...

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FDA Accepts the BLA for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review

Posted 11 days ago in New Drug Applications

November 29, 2016 - EMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE (link is external)) today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab. This review relates to avelumab's proposed use in patients with metastatic Merkel cell...

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Amicus Therapeutics Announces U.S. Regulatory Pathway for Migalastat for Fabry Disease

Posted 12 days ago in New Drug Applications

CRANBURY, N.J., Nov. 28, 2016 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a global biotechnology company at the forefront of rare and orphan diseases, announces its planned regulatory pathway to collect additional data to support full approval for the oral precision medicine migalastat for Fabry disease. Following several collaborative discussions with the U.S. Food and Drug Administration (FDA),...

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FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions

Posted 13 days ago in New Drug Approvals

REDWOOD CITY, Calif., November 27, 2016 – Relypsa, Inc., a Vifor Pharma company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) with important updates to the label of Veltassa (patiromer) for oral suspension. Veltassa’s label no longer includes a Boxed Warning regarding the separation of Veltassa and other oral medications. The updated label re...

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Intellipharmaceutics Submits NDA for Rexista (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain

Posted 2 weeks ago in New Drug Applications

TORONTO, Nov. 25, 2016 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that it has filed a New Drug Application ("NDA") with the U.S. Food and Drug...

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Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes

Posted 2 weeks ago in New Drug Approvals

PARIS, Nov. 21, 2016 /PRNewswire-USNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide*. Soliqua 100/33 is the combination of Lantus...

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Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes

Posted 2 weeks ago in New Drug Approvals

PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy 100/3.6 is a once-daily, combination of Tresiba (insulin degludec injection) and Victoza (liraglutide) injection indicated as...

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Monthly News Roundup - October 2016

Posted 5 weeks ago in Pharma Industry News

Merck’s Zinplava Approved to Fend Off Return of Clostridium Difficile Zinplava (bezlotoxumab) has been FDA-approved to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for CDI and who are at high risk for CDI recurrence. Zinplava is not an antibacterial and does not treat an active CDI infection. Zinplava is a human monoclonal antibody that b...

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Monthly News Roundup - September 2016

Posted 10 weeks ago in Pharma Industry News

Amjevita, a Biosimilar to Humira, Wins FDA Approval Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA) and is used for the treatment of seven inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. Amjevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ...

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Monthly News Roundup - August 2016

Posted 14 weeks ago in Pharma Industry News

FDA Approves Erelzi: Sandoz’s Biosimilar For Enbrel A third U.S. biosimilar has been FDA-approved; this time it’s Erelzi (etanercept-szzs), a biosimilar to Amgen’s tumor necrosis factor (TNF) blocker Enbrel. Sandoz’s Erelzi is the first approved biosimilar for etanercept, and is used for the same five indications found on the reference product Enbrel: rheumatoid arthritis, polyarticular juvenile idiopathic arthrit...

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FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu

Posted 18 weeks ago in Pharma Industry News

On August 3, 2016, the U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999. The FDA is committed to...

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Arena Pharmaceuticals Completes Enrollment in Ralinepag Phase 2 Clinical Trial for Pulmonary Arterial Hypertension (PAH)

Posted 3 days ago in Clinical Trials

SAN DIEGO, Dec. 7, 2016 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that it has completed enrollment in the ralinepag phase 2 trial. Ralinepag is an oral, selective IP receptor agonist targeting the prostacyclin pathway for the treatment of pulmonary arterial hypertension (PAH). The study enrolled approximately 60 patients at sites globally. "This marks an important step in the...

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Sage Announces Expedited Development Plan for SAGE-547 in the Treatment of Postpartum Depression based on FDA Breakthrough Therapy Meeting

Posted 4 days ago in Clinical Trials

CAMBRIDGE, Mass. December 6, 2016 --(BUSINESS WIRE)-- Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced its expedited development plan for SAGE-547 following receipt of formal meeting minutes from a breakthrough therapy meeting with the U.S. Food and Drug Administration (FDA). This...

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Theravance Biopharma Receives FDA Fast Track Designation for Velusetrag (TD-5108) for Idiopathic and Diabetic Gastroparesis

Posted 4 days ago in Clinical Trials

DUBLIN, Dec. 6, 2016 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis. Velusetrag is an oral investigational drug in development for the treatment of patients...

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Novartis presents results from first global registration trial of CTL019 in pediatric and young adult patients with r/r B-ALL

Posted 6 days ago in Clinical Trials

Basel, December 4, 2016 - Findings from a Novartis clinical trial (ELIANA) evaluating efficacy and safety of CTL019, an investigational chimeric antigen receptor T cell (CAR T) therapy, in relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) will be presented today during an oral session at the 58th American Society of Hematology (ASH) annual meeting (Abstract...

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Acetylon Presents Early Phase 1a/1b Results for Citarinostat (ACY-241) in Combination with Pomalyst and Dexamethasone Showing Promising Treatment Responses in Relapsed or Relapsed-and-Refractory Multiple Myeloma

Posted 6 days ago in Clinical Trials

BOSTON – December 4, 2016 – Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, today announced that it will present initial clinical data from a Phase 1a/1b clinical trial evaluating the safety and preliminary anti-tumor activity of the selective HDAC6 inhibitor citarinostat (ACY-241), in combination with pomalidomide (Po...

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